A Study of Azithromycin in the Prevention of Mycobacterium Avium Complex Disease (MAC) in HIV-Infected Patients
A Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Azithromycin as Prophylaxis Against the Development of Mycobacterium Avium Complex Disease in HIV-Infected People
2 other identifiers
interventional
N/A
1 country
3
Brief Summary
To evaluate the efficacy and safety of azithromycin administered once a week in the prevention of disseminated Mycobacterium avium complex (MAC) in severely immunocompromised HIV-infected patients with a CD4 count \< 100 cells/mm3.
Trial Health
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3 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
April 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Required:
- Anti-pneumocystis prophylactic therapy (dihydropteroate synthetase inhibitors with or without dihydrofolate reductase inhibitors, pentamidine).
- Allowed:
- Concomitant anti-HIV therapy (AZT, ddI, ddC) or antifungal therapy (including azoles).
- Patients must have:
- HIV infection.
- CD4 count \< 100 cells/mm3.
- No MAC positive blood cultures within 1 month prior to study entry.
- No symptoms suggestive of disseminated MAC infection (including unexplained diarrhea, fever, and night sweats) within 1 month of study entry.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Positive PPD within 3 months prior to study entry (negative PPD defined as \< 5 mm induration).
- Chest x-ray suggestive of any active disease, in particular tuberculosis.
- Known hypersensitivity to macrolide antibiotics.
- Any other acute clinical condition likely to interfere with completion of the protocol.
- Inability to care for self without considerable assistance and medical care.
- Concurrent Medication:
- Excluded:
- Other investigational new drugs (except for foscarnet or ddC) unless prior agreement has been reached between the investigator and the Pfizer project physician.
- Concomitant putative immunostimulants.
- Patients with the following prior conditions are excluded:
- History of MAC or Mycobacterium tuberculosis (MTb) infection.
- Prior Medication:
- Excluded within the past 4 weeks:
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (3)
San Diego Naval Hosp
San Diego, California, 921345000, United States
Womack Army Med Ctr / Med Clinic
Fort Bragg, North Carolina, 283075000, United States
United States Air Force Med Ctr
Lackland Air Force Base, Texas, 782365300, United States
Related Publications (1)
Oldfield EC, Dickinson G, Chung R, Wallace MR, Craig DB, Fessel WJ, Joyce MP, Mckee KT, Melcher G, Wagner KF, Williams WJ, Zajdowicz M, Heifits L, Dunne MW, Berman J. Once weekly azithromycin for the prevention of Mycobacterium avium complex (MAC) infection in AIDS patients. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:90
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-04